Human basic fibroblast growth factor is a functionally versatile but very expensive polypeptide. While there had been proposals in the past in the production of the polypeptide, many of such proposals were not concerned with producing authentic basic fibroblast growth factor, or the basic fibroblast growth factor produced did not have the native characteristics. For example, the produced basic fibroblast growth factor was not soluble, not bioactive, not cleavable, truncated, and/or with undesired modification to the C- or N-terminal. Further, the level of production was often so low that it could not justify a realistic production in a commercial sense. Yet further, some of the proposals made use of biological system which would generate undesired side products, e.g. toxics, rending the isolation of the human basic fibroblast growth factor not suitable for human application.
Cost-effective production of recombinant authentic proteins is a prerequisite for the widespread availability of the products on the market. Human basic fibroblast growth factor, notwithstanding a versatile protein shown to play important functions in various physiological processes including angiogenesis, wound healing and chondrogenesis, has not been commonly applied as expected. Authentic human basic fibroblast growth factor (bFGF) is a 16.5 kDa protein comprising 146 aa residues. However, essentially only structural analogs of bFGF of various molecular sizes are available for commercial applications. The reason is probably due to the use of conventional cloning methods, which are unable to establish a cost-effective processing protocol, to result in the production of authentic, soluble, bioactive, cleavable or cleaved, non-truncated, free of C- or N-terminal modification to the bFGF. Thus, bFGF has not been commonly available for skin care or therapeutic applications in a wide scale. Incredibly, however, despite being unauthentic, at the time when this description is being prepared bFGF analogs are already sold at extremely high prices, ranging from US$1,300 to US$2,000 per mg. Thus, only an effective method of producing genuine bFGF (and not analogs or bio-similars) cost effectively may allow user to benefit.
The present invention seeks to address the aforementioned issues, or at least to provide an alternative to the public.